Emily Sortor  |  January 15, 2020

Category: Legal News

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Makena pre-term labor drugA Makena user has filed a class action lawsuit alleging that the preterm birth drug did not actually prevent preterm labor as advertised.

The Makena false advertising class action lawsuit was filed by Angele Nelson who states that she was prescribed, injected with, and purchased Makena during her pregnancy.

She says she paid out-of-pocket for Makena, which cost hundreds of dollars per shot, but the drug did not work as advertised.

Nelson seeks damages on behalf of herself and all similarly affected customers, saying that despite its high price tag, the product was “worth zero or close to zero based on its actual attributes.”

The Makena birth drug class action lawsuit says that the medication is marketed as a hormonal drug that reduces a pregnant woman’s risk of giving birth before term.

The Makena class action lawsuit notes that the Makena website advertises the drug as meant for women who have already delivered a baby too early and are now pregnant with another baby.

According to Nelson, Makena’s maker, AMAG Pharmaceuticals, touts the efficacy of the drug and advertises it with testimonials from women about how effective the drug is.

Allegedly, one such claim comes from a woman who said that “receiving the weekly injections of Makena is giving me the peace of mind knowing that I’m doing everything I can to help prolong this pregnancy.”

The goal of the drug is to give babies who are at risk of being born prematurely more time to develop before they are born. However, Nelson says that these are misrepresentations. The drug reportedly received fast-track approval from the FDA, but multiple studies showed that Makena did not actually help prevent preterm births.

Allegedly, AMAG Pharmaceuticals holds the exclusive rights to Makena. Nelson explains that Hologic is the company that originally developed Makena and held the exclusive rights to the drug, until the company sold the exclusive rights to KV Pharmaceutical in 2011. Now, AMAG Pharmaceuticals holds the exclusive rights to Makena, after the company acquired KV Pharmaceuitcals in 2014.

According to Nelson, both KV Pharmaceutical and Hologic Inc. have both previously faced lawsuits over mislabeling or misrepresenting their drugs.

The Makena class action lawsuit goes on to say that the drug is over-priced. Nelson states that KV Pharmaceuticals continued its misdeeds in the case of its sale of Makena by abusing the Orphan Drug Act to sell Makena at exorbitant prices. 

Allegedly, the drug used to be available at $10 to $20 per injection when it was available in a generic form. When KV obtained exclusive marketing rights for the drug under the Orphan Drug Act in 2007, Makena prices allegedly skyrocketed to $1,500 per injection. Though the price was later lowered to $690 per injection, Nelson argues that this price is still financially damaging and inaccessible to many people.

This Makena class action lawsuit is similar to one filed by another customer in November.

Have you used Makena? What were your experiences with the drug?

Nelson is represented by Stuart C. Talley.

The Makena False Advertising Class Action Lawsuit is Angele Nelson v. AMAG Pharmaceuticals Inc., Case No. 2:20-at-00041, in the U.S. District Court for the Eastern District of California.

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24 thoughts onMakena Class Action Says Preterm Birth Drug Doesn’t Work

  1. Mallory Jones says:

    I was prescribed Makena injections with my 2nd baby in 2018 and a sensory disorder, children’s ibs as well as autism. My other 2 loves are just fine ans healthy as ever. I wish I would’ve known know I do how so I could’ve rejected the shots. He was born right at 37 weeks.

  2. Ileka Arrington says:

    My son was born in 2017 & was diagnosed with a sleep disorder as well as autism. I was given weekly injections by a high risk clinic of the “Makena” drug that was supposed to prevent me from having an early labor since my first son was one pound at birth

    1. Lisa says:

      Also same here my daughter was born in 2013 and she has autism

  3. Christie Walton says:

    In 2013 I was put on Makena 250 mg weekly injections starting at 16 weeks to prevent preterm labor. My daughter was stillborn. I also developed gestational diabetes. The emotional scars will never go away.

  4. Jamnesha Lyles says:

    This is just ridiculous, I tried suing but no one never contacted me, and said they never heard of me. But today I have proof and is seeking justice on hospitals and doctors. Sorry, for everyone’s pain. No one know the feeling that you felt until they have actually gone through it. I still have PTSD behind this.

  5. Virginia Madrid says:

    Took makena and now my son has autism and DDD this is not really medical help makena needs to be sued

    1. Dip says:

      My son has Autism after using makena as well

      1. Ileka Arrington says:

        Same here 😔

        1. Lisa says:

          Same here

  6. Yaneee says:

    I got the makena shot throughout my pregnancy in 2018.my son was born fine.as he turned 1 yrs.old he started to flap his arms alot.mostly when he gets excited.i questioned the dr.about the flapping and they said he might be slight autistic.he is now 3 going on 4 and flaps throughout the day not only in front of the tv. I know the shot caused this because i have 4 other children 2 were preterm and born ok.

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